Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021373
Company: HALEON US HOLDINGS
Company: HALEON US HOLDINGS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CHILDREN'S ADVIL COLD | IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE | 100MG/5ML;15MG/5ML | SUSPENSION;ORAL | Over-the-counter | None | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
04/18/2002 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21373lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21373ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-373_Ibuprofen%20Childrens%20Advil.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
03/24/2017 | SUPPL-13 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021373Orig1s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021373Orig1s013ltr.pdf | |
12/07/2012 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
08/24/2010 | SUPPL-11 | Labeling-Package Insert |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021373s011ltr.pdf |
05/19/2009 | SUPPL-9 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021373s009ltr.pdf |
12/03/2008 | SUPPL-8 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021373s008ltr.pdf |
04/04/2006 | SUPPL-5 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021373s005ltr.pdf |
01/12/2005 | SUPPL-3 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21373s003ltr.pdf |
03/25/2003 | SUPPL-1 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21373slr001ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
03/24/2017 | SUPPL-13 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021373Orig1s013lbl.pdf | |
04/18/2002 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21373lbl.pdf |
CHILDREN'S ADVIL COLD
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
SUSPENSION;ORAL; 100MG/5ML;15MG/5ML
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
---|---|---|---|---|---|---|---|
CHILDREN'S ADVIL COLD | IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE | 100MG/5ML;15MG/5ML | SUSPENSION;ORAL | Over-the-counter | No | 021373 | HALEON US HOLDINGS |
CHILDREN'S MOTRIN COLD | IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE | 100MG/5ML;15MG/5ML | SUSPENSION;ORAL | Over-the-counter | Yes | 021128 | J AND J CONSUMER INC |